Here’s a detailed introduction to CE EN455 and the associated testing methods for medical examination gloves:
🧤 CE EN455 – Detailed Introduction
EN 455 is a European standard for single-use medical gloves, ensuring their quality, safety, and performance. This standard is essential for gloves that are CE marked as Class I medical devices under the EU Medical Devices Regulation (MDR) 2017/745.
It consists of four parts, each covering a specific aspect of glove safety and performance.
📘 EN 455-1: Requirements and Testing for Freedom from Holes
Objective:
Ensure gloves act as an effective barrier against microorganisms.
Testing Method: Water Leak Test
- Each glove is filled with 1 liter of water and suspended vertically for 2 minutes.
- Any leakage (drip or visible wet patch) is considered a fail.
- Gloves are sampled and evaluated using the AQL (Acceptable Quality Level) system.
Acceptance Criteria:
- AQL ≤ 1.5 is required for medical gloves, which means fewer than 1.5% of gloves in a batch may fail.
📘 EN 455-2: Requirements and Testing for Physical Properties
Objective:
Ensure gloves are mechanically strong enough for medical use.
Testing Methods:
- Tensile Strength Test:
- Measures the maximum stress the glove can withstand before breaking.
- Typically tested using a tensile testing machine following ISO 37 or similar.
- Elongation at Break:
- Measures how much the glove can stretch before breaking (expressed as a percentage).
- Accelerated Aging:
- Gloves are aged in an oven (e.g., 70°C for 166 hours) to simulate shelf life.
- Then re-tested for tensile strength and elongation.
Minimum Performance (example values):
- Latex/Nitrile Gloves: Tensile strength ≥ 6 MPa after aging
- Vinyl Gloves: Tensile strength ≥ 3.6 MPa after aging
📘 EN 455-3: Requirements and Testing for Biological Evaluation
Objective:
Evaluate potential biological risks such as:
- Skin irritation
- Sensitization
- Endotoxin contamination
Testing Methods:
- Irritation & Sensitization Testing:
- In vitro or in vivo studies based on ISO 10993 series (especially parts 10 and 11).
- Endotoxin Testing (for surgical gloves):
- Measured in Endotoxin Units (EU) using the LAL (Limulus Amebocyte Lysate) test.
- Chemical Residues:
- Quantifies substances like latex proteins or accelerators that may cause allergies.
- Labelling Requirements:
- Results and risks must be clearly labeled and included in product documentation.
📘 EN 455-4: Requirements and Testing for Shelf Life Determination
Objective:
Ensure that gloves maintain their performance over the entire shelf life.
Testing Methods:
- Accelerated Aging:
- Gloves are stored at elevated temperature (e.g., 70°C) for a defined period.
- This simulates the effects of long-term storage.
- Post-aging Testing:
- Retest using methods from EN455-1 (holes) and EN455-2 (physical properties) to confirm continued compliance.
- Real-time Shelf Life Study:
- Supported by long-term stability data, though not always required for basic Class I devices.
✅ Summary Table
| EN455 Part | Focus Area | Key Test | Acceptance Criteria |
|---|---|---|---|
| EN455-1 | Holes/Leakage | Water leak test | AQL ≤ 1.5 |
| EN455-2 | Strength & Elasticity | Tensile & elongation | Based on glove type (e.g., ≥ 6 MPa) |
| EN455-3 | Biological Safety | Irritation, endotoxin, protein content | Must meet ISO 10993 & labeling |
| EN455-4 | Shelf Life | Accelerated aging + retesting | Maintain EN455-1 & EN455-2 compliance |
